UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001366
Receipt No. R000001660
Scientific Title Clinical study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty
Date of disclosure of the study information 2008/09/11
Last modified on 2008/09/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty
Acronym J-PSVT
Scientific Title Clinical study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty
Scientific Title:Acronym J-PSVT
Region
Japan

Condition
Condition Venous Thromboembolism
Osteoarthrosis
Classification by specialty
Cardiology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our objective is to investigate the actual situation of the prophylactic in this country for the vein thromboembolism(VTE)to break out after total joint arthroplasty and inspects the VTE onset protective efficacy of each prophylactic and is aimed at establishing a VTE appropriate(total joint arthroplasty to) a Japanese.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The DVT that was confirmed by sonography of Day10(No symptom characteristics).
DVT/PE symptom that broke out by Day25.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.The patient who is older than 20 years
old for total joint arthroplasty of
lower limbs plan cases in NHO
institution orthopedics from July,2008
to December,2009.
2.The patient that an agreement by the
document was provided.
Key exclusion criteria 1.A patient with the past of the blood
dyscrasia(a ProteinC,S,AT-3 deficiency
disease,an antiphosphatide antibody
syndrome,hemophilia)with the
solldification abnormality.
2.A atient having tha hemorrhagic mental
change caused by a disease(tha
hemorrhagic mental changes caused by a
disease of the important
internalorgans such as a digestive
ulcer,the bleeding in the skull).
3.Heart failure(NYHA classification
ciass 3 or 4)
4.Renal insufficiency(less than 30ml/min
creatinine clearance)
5.Liver function disorder(more than AST
institution standard upper limit 5
times or more than 3 times of the ALT
upper limit and total bilirubin,more
than 2 times of the upper limit).
6.The patient who plan to have
simultaneous Total joint anthroplasty
for both side.
7.The patient that Total joint
arthroplasty was enforced within the
past three months,or revisit.
8.The patient whom the chief physician
recognizes as inappropriateness for
this study participation.
9.The patient who tries artificial
feeding(tubal feeding,central vein
nourishment).
10.The patient who is not able to walk.
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Motokawa
Organization National Hospital Organization Nagasaki Medical Center
Division name Department of Orthopaedic Surgery
Zip code
Address 2-1001-1 Kubara Omura City Nagasaki 856-8562 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Hospital Organization Nagasaki Medical Center
Division name Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2008 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We examine a difference of the onset frequency of postoperative vein thromboembollsm by the kind of the preventer.

Management information
Registered date
2008 Year 09 Month 10 Day
Last modified on
2008 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.